About this trial
This is a prospective, phase 2, multicenter, open-label, single-arm study. Primary objective is to assess the efficacy of loncastuximab tesirine given as consolidation therapy after salvage immunochemotherapy in BTKi (Bruton Tyrosine Kinase inhibitors) -treated (or BTKi intolerant) R/R (Relapse or Refractory) MCL (Mantle Cell Lymphoma) patients. The sponsor of this clinical trial is Fondazione Italiana Linfomi - ETS (FIL ETS).
Eligibility criteria
Qualifiers
Histologically documented diagnosis of MCL as defined in the 2017 edition of the World Health Organization (WHO) classification
Age ≥ 18 and < 85 years
Relapsed/Refractory disease after one, two, three or four lines of treatment
Bendamustine-naive or relapsed after at least one year after the last cycle of a bendamustine-containing regimen
Disqualifiers
Subjects who have received a bendamustine containing regimen and relapsed less than one year after the end of treatment.
Known history of hypersensitivity to human antibodies.
Allogenic stem cell transplant within 6 months prior to start of first study drug.
Allogenic stem cell transplant with active / uncontrolled graft-versus-host disease.
Trial design
Treatments tested in this trial
- Consolidation with ADCT-402 (loncastuximab tesirine) after salvage immunochemotherapy at standard dose (R-BAC, Rituximab - Bendamustine, Ara-C))
- Consolidation with ADCT-402 (loncastuximab tesirine) after salvage immunochemotherapy at reduced dose (R-BAC, Rituximab - Bendamustine, Ara-C)